Clinical Trial: Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase 2a, Open-label, Proof of Concept Study to Determine the Efficacy and Safety of Etrasimod (APD334) in Patients With Pyoderma Gangrenosum

Brief Summary: The purpose of this Phase 2a, open label, proof-of-concept clinical study is to assess the efficacy and safety of etrasimod (APD334) in patients with Pyoderma Gangrenosum.

Detailed Summary:
Sponsor: Arena Pharmaceuticals

Current Primary Outcome:

  • Exploratory endpoint - Change from baseline in: Physician Global Assessments for active skin manifestations. [ Time Frame: Week 12 ]

    Assessment of target lesion/ulceration:

    1. (score 0) Total resolution of target ulcer with no signs of active PG
    2. (score 1) Almost completely healed target ulcer with only minimal signs of active PG
    3. (score 2) Evidence of target ulcer healing which involves at least 50% of ulcer/ulcer margin
    4. (score 3) Evidence of target ulcer healing which involves less than 50% of ulcer/ulcer margin
    5. (score 4) No evidence of target ulcer healing
  • Exploratory endpoint - Change from baseline in Patient Global Assessments for active skin manifestations: visual analog scale for assessment of severity of the disease and severity of pain by patient. [ Time Frame: Week 12 ]
  • Exploratory endpoint - Change from baseline in Dermatology Life Quality Index (to measure how much a patient's life is affected through their skin problems). [ Time Frame: Week 12 ]
  • Exploratory endpoint - Change from baseline in C-reactive protein levels. [ Time Frame: Week 12 ]
  • Exploratory endpoint - Assessments of target lesions. [ Time Frame: Week 12 ]
    Changes in surface area
  • Exploratory endpoint - Assessment of punch biopsies. [ Time Frame: Week 12 ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Arena Pharmaceuticals

    Dates:
    Date Received: February 17, 2017
    Date Started: March 2017
    Date Completion:
    Last Updated: March 2, 2017
    Last Verified: March 2017